FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACE 101H
K Number: K970497
·
Decision Jun 4, 1997
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
2
Review Days
114
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Basic Information
- Device Name
- PACE 101H
- K Number
- K970497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sulzer Oscor, Inc.
- Date Received
- February 10, 1997
- Decision Date
- June 4, 1997
- Product Code
- DTE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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Other Clearances by Sulzer Oscor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990142 | HT, MODEL HT PB | Jul 30, 1999 | Substantially Equivalent - Subject to Tracking Reg. |